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510(k) K955250

Device
QI GONG MASSAGER
Applicant
EAST HEALTH DEVELOPMENT GROUP, INC.
510(k) number
K955250
Product code
IRO  
Decision
Substantially Equivalent For Some Indications (SN)
Decision date
1996-02-08
Date received
1995-11-13
Regulation
890.5975
Classification name
Vibrator, Therapeutic
Medical specialty
Physical Medicine
Review panel
Physical Medicine
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
XIAOMING WANG
Address
P.O. Box 947 Tustin CA US 92680 92680

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code IRO  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K955160COMFORT, MUSCLE, CORDLESS MASSAGER, BATTERY POWERED OPERATED MASSAGEREverapex Design & Marketing Corp.1996-02-08
K954203MASSAGER THERAPUTIC, ELECTRICCisco Sales Corp.1995-12-11
K952916SHIATSU MASTER MASSAGER CUSHIONKinsei Shiatsu, Inc.1995-08-28
K951414CHAMPION PHYSIOACOUSTICC RECLINER-TRANSPORTER CHAIRChampion Mfg. Corp.1995-08-11
K950441CONAIR FAMILY FITNESS BODY ENERGYConair Corp.1995-07-18
K946382SKALPI 3200Wiscco Development, Inc.1995-05-30
K950410CONAIR BODY AND SOLEConair Corp.1995-05-23
K944909WAHL FRESH FACEWahl Clipper Corp.1995-05-08
K950400HAND MASSAGE UNITUltrassage, Inc.1995-03-30
K945603CORDLESS MASSAGER WITH HEAT ( VARIOUS BRAND NAMES)Headwaters, Inc.1995-02-09
K940582MASSAGING HELMET C.F. HANSEN DESIGNPhilco Ushuaia1995-01-30
K943730SQUEEZE PLAYConair Corp.1994-11-28
K941412WAHL COMPACT COMFORT MASSAGERWahl Clipper Corp.1994-06-09
K940837WAHL(R) FOOT COMFORT MASSAGERWahl Clipper Corp.1994-06-09
K934886NEXT WAVE PHYSIOACOUSTIC MATTRESSNext Wave, Inc.1994-06-09

Legacy Summary#

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FDA Review#

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